Spinal fluid collection system

ABSTRACT

A cerebrospinal fluid collection system and method for conveniently and safely holding in a test tube rack, during a spinal tap and collection procedure, sterile test tubes and spinal needles, needle sleeves and stylettes. A test tube rack has four holes for holding four sterile test tubes, two needle holes for holding a spinal needle, stylette or needle sleeve, and a handle for the physician to hold when moving the test tube rack during the CSF procedure. The handle can be held on the left side by a left hand, on the right side by a right hand, or in the front by either hand. The test tube rack also allows the physician to see when the appropriate amount of cerebrospinal fluid has been collected in each test tube, while such test tube is being held in the test tube rack. The test tube rack may be prepackaged with the other needed items in a sterile package.

BACKGROUND

A spinal tap is a procedure which takes samples of a patient'scerebrospinal fluid (CSF). Spinal taps are performed when the physiciansuspects that the patient may have bleeding (such as subarachnoidhemorrhage) or an infection of the central nervous system (such asmeningitis or encephalitis). These procedures are often performed in theemergency room but are also performed in a doctor's office or in ahospital setting.

Usually, before beginning a spinal tap procedure, the physician, oranother medical professional arranges the contents of a spinal tap “kit”on a tray, positioned next to where the physician will be sitting toperform the procedure. The “kit” usually consists of four sterile tubes,a spinal needle (with a stylette inserted through the spinal needle),along with items for sterilizing the patient's skin and draping thepatient. Sometimes a test tube rack to hold the tubes is also positionedon the tray. Before the procedure, the physician or another medicalprofessional removes all of these items from their sterile packaging,unscrews the caps from the tubes, and arranges everything on the trayfor easy access during the procedure.

Usually, the patient is asked to lie down in a curled-up position,exposing the back. The physician then sterilizes the patient's back andnumbs the skin around the insertion point. In other words, the physicianor other medical professional does a “sterile prep and drape.” Thephysician then inserts a spinal needle, with a stylette inside thespinal needle, between the patient's vertebrae (usually in the L3-4 orL4-5 interspace) and advances the needle until the needle has reachedthe fluid-filled area surrounding the patient's spine, the dural space.The stylette is used to prevent the tip of the spinal needle frombecoming blocked by tissue as the needle is inserted through thepatient's skin and other tissues. Once the needle is in place, thestylette is removed from the spinal needle and usually placed on thesterile tray. CSF flows through the needle and drips from the proximalend of the needle. The physician then takes four sterile tubes (threefor pediatric patients) in turn from the tray and fills the tubes eachwith approximately 1 ml (or 1 cc) of CSF.

Usually, the physician must reach for a (closed or open) tube on thetray, collect an appropriate amount of CSF in the tube, seal the caponto the tube (so that the fluid does not spill), reach over to thetray, lay the tube down on the tray, pick up another tube from the trayand repeat the process. If the physician is using a test tube rack, thephysician must take an open tube from the test tube rack, collect anappropriate amount of CSF in the tube, replace the tube into the testtube rack on the tray, pick the next open tube from the test tube rack,and repeat the process. Currently, each test tube itself must be heldbeneath the proximal end of a spinal needle as the spinal fluid iscollected. Space is tight between the physician and the patient with aspinal needle protruding from his/her back.

Once collected, CSF is then sent to a laboratory to determine if thepatient is suffering from viral (for example, Enteroviruses and Herpesviruses, as well as Arboviruses, Rabies or measles among other viralagents), bacterial (including Haemophilus influenza, Streptococcuspneumoniae, Neisseria meningitidis, and also Listeria monocytogenes,Staphylococcus epidermidis, Staphylococcus aureus, Mycobacteriumtuberculosis, Escherichia Coli or other Gram negative enteric bacteria)or fungal (including Cryptococcus neoformans, Coccidioides immitis,among other fungal agents) infection of the brain or supportingstructures, among other possible diagnoses. The CSF is also examined forwhite and red blood counts and chemical components.

This procedure is very uncomfortable for the patient. The procedure isespecially uncomfortable if the patient is very young or very sick,which is often the case. Reducing the duration of this procedure wouldreduce the duration of the patient's discomfort. This procedure alsorepresents significant risk to the patient. Time is ticking while thephysician puts the stylette down on the tray, reaches for a test tube,places the test tube in the proper position to collect CSF, fills thetube, screws the cap back on and reaches for the next tube. All thewhile, CSF is flowing from the patient. Patients may develop severe sideeffects from the loss of too much CSF, including severe headaches. Therisk of the patient moving and causing injury exists for the duration ofthe procedure. These risks include a risk of lacerating a spinal nerve,lacerating the meninges (causing permanent or persistent leaks of CSF),or bleeding, which complicates the interpretation of laboratory results.These risks are increased in very young patients who are more likely tomove during the procedure. In addition, there is a risk of respiratoryarrest in neonates who are held in a curled-up position for the durationof the procedure. Reducing the duration of this procedure reduces theserisks. In addition, these procedures are often performed in emergencyrooms where physician time is at a premium. Minutes shaved from aprocedure, performed several times over the course of a shift, mayresult in the physician being able to tend to additional patients.

OBJECTS

It is a primary object and feature of the present invention to provide acerebrospinal fluid collection system which allows a physician to betterprepare for a spinal tap procedure, reduce the time necessary to carryout a spinal tap procedure, and reduce the risk of injury and severeside affects related to spinal tap procedures. It is a further objectand feature of this invention to provide a test tube rack which is nottoo bulky, too difficult to hold, and/or too unwieldy to be used to holdtest tubes while CSF is being collected. It is a further object andfeature of the present invention to provide a test tube rack which isinexpensive to manufacture, disposable, sterilizable, see-through andlightweight. Other objects and features of this invention will be shownby the following descriptions and claims.

SUMMARY

According to a preferred embodiment of the present invention, thisinvention provides a spinal fluid collection system for use by a medicalprofessional for collecting, from a spinal tap into a plurality of CSFtubes, multiple samples of cerebrospinal fluid from a patient,comprising, in combination: a plurality of CSF tubes structured andarranged to receive, seal, and transport cerebrospinal fluid; at leastone spinal tap assembly structured and arranged to tap into the patientto obtain a flow of cerebrospinal fluid; and a holder structured andarranged to stably hold such CSF tubes when such holder is in an uprightposition; wherein such holder comprises a handle structured and arrangedto assist single-hand manipulation of such holder by the medicalprofessional during the collecting of the cerebrospinal fluid directlyfrom such spinal tap into such CSF tubes, when held by such holder, in acontinuing manner without the need to grasp any such CSF tube during thecollecting. It also provides such a system further comprising a sealedinternally-sterile package sealing such holder and such CSF tubes. Andwherein such package further seals at least one such spinal tapassembly; and further, wherein such handle is structured and arranged tobe grasped by either a right hand or a left hand of the medicalprofessional.

Additionally, it provides such a system wherein such holder isstructured and arranged to stably hold, when such holder is in anupright position, any element selected from the group consisting of aspinal needle, a spinal needle sleeve, a spinal needle stylette, aspinal needle sleeve holding a spinal needle, a spinal needle sleeveholding a spinal needle and a stylette.

It also provides such a system wherein such holder is structured andarranged to stably hold four of the CSF tubes when such holder is in anupright position; wherein such holder is structured and arranged tostably hold, when such holder is in an upright position, at a firstportion of such holder any such element selected from such group; andwherein such holder is structured and arranged to stably hold, when suchholder is in an upright position, at a second portion of such holder anysuch element selected from such group. And it further provides such asystem wherein such holder further comprises four first verticalcavities each structured and arranged to support one of the CSF tubes;and at least two second vertical cavities each structured and arrangedto support any such element selected from such group.

Moreover, it provides such a system wherein such holder comprises anessentially-transparent plastic material. It also provides such a systemwherein such handle is structured and arranged to be grasped by either aright hand or a left hand of the medical professional. And it providessuch a system wherein such first and second vertical cavities arearranged along a horizontal longitudinal row, having a midpoint, of suchholder; and such handle is essentially horizontal and symmetrical withrespect to such midpoint. And it further provides such a system whereinsuch handle comprises the furthest longitudinal horizontal extensions ofsuch holder.

According to a preferred embodiment of the present invention, thisinvention also provides a spinal fluid collection system for use by amedical professional for collecting, from a spinal tap into a pluralityof CSF tubes, multiple samples of cerebrospinal fluid from a patient,comprising: a holder structured and arranged to stably hold the CSFtubes when such holder is in an upright position; wherein such holdercomprises a handle structured and arranged to assist single-handmanipulation of such holder by the medical professional during thecollecting of the cerebrospinal fluid directly from the spinal tap intothe CSF tubes, when held by such holder, in a continuing manner withoutthe need to grasp directly any of the CSF tubes during the collecting;and wherein such holder is structured and arranged to stably hold, whensuch holder is in an upright position, any element selected from thegroup consisting of a spinal needle, a spinal needle sleeve, a spinalneedle stylette, a spinal needle sleeve holding a spinal needle, aspinal needle sleeve holding a spinal needle and a stylette. Further, itprovides such a system wherein such holder is structured and arranged tostably hold four of the CSF tubes when such holder is in an uprightposition; wherein such holder is structured and arranged to stably hold,when such holder is in an upright position, at a first portion of suchholder any such element selected from such group; and wherein suchholder is structured and arranged to stably hold, when such holder is inan upright position, at a second portion of such holder any such elementselected from such group. And also, wherein such holder furthercomprises four first vertical cavities each structured and arranged tosupport one of the CSF tubes; and at least two second vertical cavitieseach structured and arranged to support any such element selected fromsuch group.

Still further, it provides such a system wherein such holder comprisesan essentially-transparent plastic material. And even further, itprovides such a system wherein such handle is structured and arranged tobe grasped by either a right hand or a left hand of the medicalprofessional. Also, it provides such a system wherein such first andsecond vertical cavities are arranged along a horizontal longitudinalrow, having a midpoint, of such holder; and such handle is essentiallyhorizontal and symmetrical with respect to such midpoint. And itprovides such a system wherein such handle comprises a horizontal platecomprising the furthest horizontal extensions of such holder in at leasttwo directions; and wherein such handle comprises the furthestlongitudinal horizontal extensions of such holder.

According to another preferred embodiment of the present invention, thisinvention also provides a spinal fluid collection system for use by amedical professional for collecting, from a spinal tap into a pluralityof CSF tubes, multiple samples of cerebrospinal fluid from a patient,comprising the steps of: providing a CSF-tube holder having a handle andneedle-holder to stably hold a spinal needle assembly; arranging atleast three open CSF tubes in such holder; inserting a spinal needlecontaining a stylette between a patient's vertebrae until a tip of thespinal needle reaches a dural space; removing such stylette from suchspinal needle; placing such stylette in such needle-holder of suchholder; grasping such holder by such handle; placing such holder underthe proximal end of such spinal needle so that CSF drips from suchproximal end of such spinal needle into a first such open test tube;determining when such first open test tube contains a sufficient amountof CSF; shifting such holder so that CSF drips from such proximal end ofsuch spinal needle into a second such open test tube; determining whensuch second open test tube contains a sufficient amount of CSF; shiftingsuch holder so that CSF drips from such proximal end of such spinalneedle into a third such open test tube; determining when such thirdopen test tube contains a sufficient amount of CSF; removing suchstylette from such needle-holder; replacing such stylette inside suchspinal needle; removing such spinal needle containing such stylette fromthe dural space; placing such spinal needle containing such styletteinto such needle-holder; and closing such three open test tubes.

Further it provides such a system further comprising the steps of:placing a needle sleeve into such needle-holder of such holder; andplacing such spinal needle containing such stylette into such needlesleeve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a preferred embodiment of the spinalfluid collection system of the present invention, and furtherillustrating a hand holding such system.

FIG. 2 is a top view of the test tube rack of the preferred embodimentof FIG. 1.

FIG. 3 is a front view of the preferred embodiment of FIG. 1, butillustrating the test tube rack holding four tubes, a needle in itsneedle sleeve and a stylette.

FIG. 4 is a partial front view of the preferred spinal fluid collectionsystem, illustrating the first step in the method of using such system,assembling the equipment.

FIG. 5 is a pictorial view illustrating a subsequent step, inserting thespinal needle into a back.

FIG. 6 is a partial close-up view illustrating a subsequent step,removing the stylette from the needle.

FIG. 7 is a partial perspective view illustrating a subsequent step,collecting CSF into a tube held in the test tube rack.

FIG. 8 is a partial front view illustrating an additional step,collecting CSF into another tube held in the test tube rack.

FIG. 9 is a front view illustrating an additional step, collecting CSFinto a final tube held in the test tube rack.

FIG. 10 is a front view illustrating an additional step, closing thetubes and replacing the needle into the rack.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODES OFPRACTICE

FIG. 1 is a perspective view of a preferred embodiment of the presentinvention illustrating a hand 20 holding the system 19, which embodiesherein a spinal fluid collection system for use by a medicalprofessional for collecting, from a spinal tap into a plurality of CSFtubes, multiple samples of cerebrospinal fluid from a patient.Illustrated in FIG. 1 is a preferred embodiment of the test tube rack21, embodying herein a holder structured and arranged to stably holdsuch CSF tubes when such holder is in an upright position. The test tuberack 21 is preferably made of clear (i.e. see-through), lightweight,sterilizable, disposable, medical-grade plastic material. The test tuberack 21 has a top shelf 22, a handle shelf 40, a bottom shelf 41, aninside shelf 42, two side panels 37, and two open sides 35.

Top shelf 22 preferably has four test tube holes 23 arranged in a rowacross top shelf 22. These test tube holes 23 are preferably justslightly larger than the outside diameter of the test tubes 24 so thatthe test tubes 24 easily slide through the test tube holes 23 in topshelf 22 but also restrict the movement of the test tubes 24 within thetest tube holes 23. The inside shelf 42 also preferably has four testtube holes 23, sized to contain test tubes 24, arranged in a row acrossinside shelf 42, and aligned directly below the four test tube holes 23in top shelf 22. Preferably, each test tube 24 (embodying herein aplurality of CSF tubes structured and arranged to receive, seal, andtransport cerebrospinal fluid) can slide through one of the four testtube holes 23 in the top shelf 22, slide through the corresponding testtube hole 23 in the inside shelf 42, and come to rest against bottomshelf 41 (which preferably does not have holes but which may haveindentations if desired to assist stabilizing test tubes resting in therack).

Also illustrated in FIG. 1 are needle holes 25, preferably arranged withone needle hole 25 at each end of the row of four test tube holes 23 intop shelf 22, this arrangement embodying herein a holder wherein suchholder is structured and arranged to stably hold, when such holder is inan upright position, at a first portion of such holder any such elementselected from such needle assembly group; and wherein such holder isstructured and arranged to stably hold, when such holder is in anupright position, at a second portion of such holder any such elementselected from such group. And this arrangement further embodies whereinsuch holder further comprises four first vertical cavities eachstructured and arranged to support one of the CSF tubes, and at leasttwo second vertical cavities each structured and arranged to support anysuch element selected from such needle assembly group. Preferably,inside shelf 42 also has two needle holes 25 arranged directlyunderneath the needle holes in top shelf 22 so that a spinal needle 26,or a stylette 28, or a needle sleeve 27, or any combination of these,can preferably slide through the needle hole 25 in the top shelf 22,slide through corresponding needle hole 25 in the inside shelf 42, andcome to rest against the bottom shelf 41.

Preferably, bottom shelf 41 has a slight indentation 44 (see FIG. 7) inits inside surface 54 (see also FIG. 7), aligned directly underneath theneedle hole 25 in inside shelf 42 and top shelf 22 so that spinal needle26 will be caught inside the slight indentation. Preferably, this slightindentation 44 will reduce the risk of the spinal needle 26, the needlesleeve 27 and/or the stylette 28 (this assembly embodying herein atleast one spinal tap assembly structured and arranged to tap into thepatient to obtain a flow of cerebrospinal fluid), placed through theneedle holes 25 in top shelf 22 and inside shelf 42, sliding out of thetest tube rack 21, even if the test tube rack 21 is tilted at an angle.In addition, these two (preferably identical) needle holes 25 arearranged at both ends of the test tube holes 23 so that a physicianusing the test tube rack 21 might be comfortable using the test tuberack left-handed or right-handed. Preferably, the spinal needle 26 is an22G3½ (1.27 mm×8.89 cm Leur-Lok (™) hub) spinal needle with aQuincke-type point, available through Becton-Dickinson, Franklin LakesN.J. 07417, reorder No. 405184.

With further reference to FIG. 1, the test tubes 24 typically havescrew-on caps 31. These screw-on caps 31 are connected to the test tubes24 by flexible plastic tabs 32. The flexible plastic tabs 32 areattached to the test tubes 24 by rings 34 around the test tubes 24. Thetest tubes 24 are preferably made of sterilizable, lightweight, plasticmaterial. Test tubes 24 have markings 48 (see FIG. 3) illustrating onemilliliter (ml) or one cubic centimeter (cc) increments (up to 8 cc or 8ml) so that the physician collecting CSF can tell when 1 cc of fluid hasbeen collected. The bottom ends of test tubes 24 have invertedcone-shaped (tip down) internal surfaces so that the test tubes 24 canbe spun in a centrifuge, allowing solid materials to settle in thebottom of the tubes. Such test tubes 24 are preferably approximately 4½inches long, approximately ⅝ inch in outside diameter, standard CSFtubes. These test tubes 24 are well known in the art and readilyavailable from well-known sources.

Top shelf 22 is attached at each end to side panels 37. Side panels 37are preferably made of the same lightweight, clear (i.e. see-through)plastic used to make top shelf 22 and the rest of the structure of thetest tube rack 21, thus embodying herein that such holder comprises anessentially-transparent plastic material. Side panels 37 have internalsurfaces 38 and external surfaces 39. Preferably, integrally attached tothe external surface 39 of side panels 37 is a handle shelf 40.Preferably, handle shelf 40 wraps around one of the open sides 35,making that open side the front 43 of the test tube rack 21.

Alternatively, handle shelf 40 may preferably extend through the testtube rack 21, contain four test tube holes in a row and two needleholes, aligned between top shelf 22 with its four test tube holes 23 andtwo needle holes 25 and inside shelf 42, with its four test tube holes23 and two needle holes 25, so that test tubes 24 can pass through topshelf 22, handle shelf 40 and inside shelf 42 before coming to restagainst bottom shelf 41. Handle shelf 40 is preferably shaped as shownso that a physician can hold the test tube rack 21 with a left hand onthe left side 45 of the handle shelf 40 (left hand not shown), with aright hand 20, on the right side 46 of handle shelf 40, or with eitherhand from the front 47 of the handle shelf 40 (such shelf embodyingherein a handle structured and arranged to assist single-handmanipulation of such holder by the medical professional during thecollecting of the cerebrospinal fluid directly from such spinal tap intosuch CSF tubes, when held by such holder, in a continuing manner withoutthe need to grasp any such CSF tube during the collecting). This handlearrangement also embodies a handle arrangement wherein such first andsecond vertical cavities are arranged along a horizontal longitudinalrow, having a midpoint, of such holder, and such handle is essentiallyhorizontal and symmetrical with respect to such midpoint, and whereinsuch handle comprises the furthest longitudinal horizontal extensions ofsuch holder.

Top shelf 22, inside shelf 42 and bottom shelf 41 are integrallyattached to the internal surfaces 38 of side panels 37. Preferably, thewhole test tube rack 21, including top shelf 22, side panels 37, handleshelf 40, inside shelf 42 and bottom shelf 41 are all made in the samemold of the same see-through lightweight, sterilizable, disposable,medical grade plastic material. Less preferably, the test tube rack 21,including top shelf 22, side panels 37, inside shelf 42 and bottom shelf41 are all made in the same mold of the same see-through plasticmaterial, with the handle shelf 40 being poured separately, in aseparate mold, but using the same material. Preferably, handle shelf 40,molded separately, can be attached to the rest of the test tube rack 21by heat welding, gluing or other appropriate attachment method. Lesspreferably, any subset of the test tube rack 21, such as the top shelf22 and the handle shelf 40, attached by side panels 37, may be moldedseparately from any remaining subset of the test tube rack 21 (such asthe inside shelf 42 and the bottom shelf 41), attached by side panels37, and later connected together by heat welding, gluing or otherattachment method. Separate molding of subsets of parts of the test tuberack 21, although less preferable, may be necessary in suchcircumstances which, for example, make the molding and manufacturingprocess easier and less expensive.

FIG. 2 is a top view of the preferred embodiment of test tube rack 21.FIG. 2 illustrates the four test tube holes 23, arranged in a row, sizedto hold test tubes 24, and also illustrates the two needle holes 25sized to hold a spinal needle 26, a needle sleeve 27 or a stylette 28(see FIG. 1). FIG. 2 also shows a preferred size and shape of handleshelf 40. Preferably handle shelf 40 is large enough so that a hand 20(see FIG. 1), can hold the test tube rack 21 on the left side 45 ofhandle shelf 40, on the right side 46 of handle shelf 40, or on thefront 47 of handle shelf 40. The shape illustrated in FIG. 2 ispreferable for the handle shelf 40. Other shapes, including separateleft and right wing handles, or a separate front handle, a square-shapedhandle shelf, or more rounded shapes, may all be preferred underspecific circumstances of cost, manufacture, use, etc.

FIG. 3 illustrates the test tube rack 21 containing a stylette 28 byitself, four test tubes 24, and a spinal needle 26 containing a stylette28 encased in its needle sleeve 27, each passing through holes in topshelf 22 and inside shelf 42 (See FIG. 1), and resting against bottomshelf 41 (these descriptions embodying herein wherein such holder isstructured and arranged to stably hold, when such holder is in anupright position, any element selected from the group consisting of aspinal needle, a spinal needle sleeve, a spinal needle stylette, aspinal needle sleeve holding a spinal needle, and a spinal needle sleeveholding a spinal needle and a stylette). Inside shelf 42 is preferablyarranged so that, when held in test tube rack 21 in this manner, the 1cc marking 49 on the test tubes 24 can readily be seen by a personholding the test tube rack 21. In other words, it is preferable that thephysician can see when the test tubes 24 are filled with 1 cc (or 1 ml)of fluid when the test tubes 24 are contained in the test tube rack 21.

FIG. 4 illustrates the first step—assembling the equipment—in the methodof using the test tube rack 21 and system 19 of the present invention.The spinal needle 26 containing a stylette 28, encased in a needlesleeve 27, can preferably be removed from its sterile packaging andplaced through its corresponding needle hole 25 (see FIG. 1) in the testtube rack 21. The four test tubes 24 can preferably be removed fromtheir sterile packaging, their lids 31 can be unscrewed, and they can beplaced in their corresponding holes 23 (see FIG. 1). As an alternatepreferred embodiment, the four test tubes 24 can be placed in the testtube rack 21 and then sterilized along with the test tube rack 21 andpackaged together in one sterile packet. In other words, it ispreferable that the test tube rack 21 containing the four test tubes 24,with their screw-on caps 31 unscrewed (but attached to the test tubes bythe plastic rings 33 and plastic tabs 32 described above) be sterilizedand packaged together in a single package. In that way, all thephysician or other medical professional has to do to prepare for aspinal tap procedure is pull two sterile packages open (one for theneedle, stylette and sleeve and one for the tubes and rack) and placethe test tube rack 21 containing the open tubes 24 on the proceduretray. Alternately, the test tube rack 21 may preferably be placed in asterile package alone.

As another alternate preferred embodiment, the test tubes 24, the testtube rack 21 and the spinal needle 26 (along with the stylette 28 andthe needle sleeve 27) can be prepackaged and sterilized together—i.e.,the elements of system 19 in the condition shown and as illustrated inFIG. 4—so that the physician only has to open one package 70 to have allof these items ready to perform a spinal tap procedure. Prepackagingsome or all of these necessary tools together, using this test tube rack21, decreases the amount of time necessary for the physician or othermedical professional to spend setting up for a spinal tap procedure.These described prepackages embody herein a sealed internally-sterilepackage sealing such holder and such CSF tubes and further wherein suchpackage further seals at least one such spinal tap assembly.

FIG. 5 illustrates a subsequent step in the method of using a preferredembodiment of the present invention. Once the physician or other medicalprofessional has assembled all of the equipment that will be necessaryto perform the procedure, including the four test tubes 24 (see FIG. 4)and the spinal needle 26 with its stylette 28 is inserted through thespinal needle 26, then the patient must be prepared. Typically, thepatient is placed on his or her side, exposing his/her back 50. Thepatient's back 50 is sterilized and the skin around the site 60 ofinsertion is numbed. In other words, the patient is “draped andprepped.” Preferably, the spinal needle 26 (with the stylette 28inserted through the spinal needle 26), is inserted at site 60 betweenthe patient's vertebrae, illustrated in FIG. 5 and discussed above.

FIG. 6 illustrates that, once the spinal needle 26 is inserted into thepatient's back 50 and positioned correctly, the stylette 28 ispreferably removed from the spinal needle 26. Less typically, the spinalneedle 26 may be inserted into the dural space without the stylette 28.Some practitioners prefer not to use the stylette 28 at all. In thatcase, the preferable method described herein is modified only in thatthe stylette 28 is discarded when the sterile packaging containing thespinal needle 26 is opened.

FIG. 7 illustrates subsequent steps in the method of using the preferredembodiment of the present invention, showing the collecting of CSF 51into a test tube 24 held in the test tube rack 21. Once the spinalneedle 26 is inserted into a back 50, and the stylette 28 is removedfrom the spinal needle 26, as illustrated in FIG. 6, the stylette 28 canbe placed (as shown in FIG. 7) into the test tube rack 21, through aneedle hole 25. Once the stylette 28 is removed from the spinal needle26, CSF 51 flows through the spinal needle and drips from the proximalend 52 of the spinal needle 26. The whole test tube rack 21 containingfour open test tubes 24 (or three for a pediatric procedure) canpreferably be conveniently placed (as by the physician's hand 20, seeFIG. 1) under the proximal end 52 of the spinal needle 26 to collect CSF51. When a sufficient amount of CSF 51 has been collected, as indicatedby the markings 48 on the test tube 24, the physician preferably simplymoves the entire test tube rack 21, so that the next unfilled test tube24 is aligned under the proximal end 52 of the spinal needle 26,inserted into the patient's back 50. FIG. 7 also illustrates thepreferable slight indentation 44 in the inside surface 54 of the bottomshelf 41 of the test tube rack 21 to assist in preventing the spinalneedle 26, or needle sleeve 27, or stylette 28 from moving.

FIG. 8 illustrates another step in the method of using the preferredembodiment of the present invention, filling another test tube 24 withCSF 51. FIG. 8 illustrates the test tube rack 21 containing four testtubes 24, the stylette 28 and the needle sleeve 27. This assembly 53(the test tube rack 21 containing four test tubes 24, the stylette 28,and the needle sleeve 27) is the preferable assembly 53 duringcollection of CSF 51. The assembly 53 is preferably simply shifted a fewcentimeters in one direction or the other (depending on the handednessand preferences of the practitioner) so that the next test tube 24 isaligned underneath the proximal end 52 of the spinal needle 26 tocollect CSF 51.

FIG. 9 illustrates an additional step in the method of using thepreferred embodiment of the present invention, filling the final testtube 24 with CSF 51. Again, the assembly 53 is preferably simply shifteda few centimeters in one direction or the other (depending on thehandedness and preferences of the practitioner) so that the final testtube 24 is aligned underneath the proximal end 52 of the spinal needle26 to collect CSF 51. FIG. 9 also illustrates that the inside shelf 42of the test tube rack 21 is preferably aligned so that the 1 cc markings49 on the test tubes 24 are clearly visible when the test tubes 24 arecontained in the test tube rack 21.

FIG. 10 illustrates a subsequent step in the method of using thepreferred embodiment of the present invention, closing the screw-on caps31 on the test tubes 24. Once an appropriate amount of CSF 51 has beencollected in each test tube 24, the stylette 28 is preferablyre-inserted into the spinal needle 26 before the spinal needle 26 isremoved from the patient's back 50. It is preferable to re-insert thestylette 28 through the spinal needle 26 before removing the spinalneedle 26 because it may assist in preventing leakage of CSF 51 afterthe spinal needle 26 is removed. Once removed from the patient's back50, the spinal needle 26, containing the stylette 28, may preferably beplaced in the test tube rack 21, through a needle hole 25. Or,alternatively, if the stylette is not re-inserted through the spinalneedle 26 before the spinal needle 26 is removed from the patient's back50, the stylette 28 may remain in place in the test tube rack 21 asshown in FIG. 10, and the spinal needle 26 may be placed into the needlesleeve 27 which is already inserted through a needle hole 25. When thespinal needle 26 is replaced into the test tube rack 21 in either ofthese preferred ways, the danger of needle sticks is reduced. Byreplacing the spinal needle 26 in this way, the needle is placed in apredictable position, needle tip down, so that the physician or othermedical professional who cleans up after the procedure is not faced withpicking up a loose contaminated needle on a tray. Or, if the needle isplaced back through the needle sleeve 27, the physician or other medicalprofessional avoids the potentially dangerous activity of trying toslide a needle, which has had contact with bodily fluids of a patient,into a needle sleeve 27. Once the spinal needle 26 is removed from thepatient and placed into the test tube rack 21, the screw-on caps 31 ofthe test tubes 24 can preferably simply be screwed down onto the testtubes 24, creating a seal to prevent leakage or spillage of CSF 51 fromthe test tubes 24 as they are transported to a laboratory for analysis.

This described method embodies herein a method comprising the steps of:providing a CSF-tube holder having a handle and needle-holder to stablyhold a spinal needle assembly; arranging at least three open CSF tubesin such holder; inserting a spinal needle containing a stylette betweena patient's vertebrae until a tip of the spinal needle reaches a duralspace; removing such stylette from such spinal needle; placing suchstylette in such needle-holder of such holder; grasping such holder bysuch handle; placing such holder under the proximal end of such spinalneedle so that CSF drips from such proximal end of such spinal needleinto a first such open test tube; determining when such first open testtube contains a sufficient amount of CSF; shifting such holder so thatCSF drips from such proximal end of such spinal needle into a secondsuch open test tube; determining when such second open test tubecontains a sufficient amount of CSF; shifting such holder so that CSFdrips from such proximal end of such spinal needle into a third suchopen test tube; determining when such third open test tube contains asufficient amount of CSF; removing such stylette from suchneedle-holder; replacing such stylette inside such spinal needle;removing such spinal needle containing such stylette from the duralspace; placing such spinal needle containing such stylette into suchneedle-holder; and closing such three open test tubes; and furthercomprising the steps of placing a needle sleeve into such needle-holderof such holder, and placing such spinal needle containing such styletteinto such needle sleeve.

Although applicant has described applicant's preferred embodiments ofthis invention, it will be understood that the broadest scope of thisinvention includes such modifications as diverse shapes and sizes,materials and methods of manufacture. Such scope is limited only by thebelow claims as read in connection with the above specification.Further, many other advantages of applicant's invention will be apparentto those skilled in the art from the above descriptions and the belowclaims.

1-22. (canceled)
 23. A holder for apparatus for the collection ofcerebrospinal fluid (CSF), for stably holding in a substantially uprightposition CSF collection containers, said holder comprising: ahorizontally disposed top shelf member having a plurality of firstopenings; a horizontally disposed inside shelf member having a pluralityof second openings, wherein the second openings are substantiallyaligned with the first openings in the top shelf member; a substantiallyhorizontally disposed handle shelf member; a horizontally disposedbottom shelf member against which the bottoms of the containers rest;and substantially vertically disposed side panels connected to the topshelf member, the inside shelf member, the handle shelf member, and thebottom shelf member.
 24. The holder of claim 23, wherein said holder iscomprised of transparent material.
 25. The holder of claim 23, whereinsaid holder is further comprised of sterilizable material.
 26. Theholder of claim 23, wherein said holder comprises openings for four CSFcollection containers.
 27. The holder of claim 23, wherein the first andsecond openings each are linearly arranged.
 28. The holder of claim 23,comprising two vertically disposed side panels disposed opposite eachother whereby the holder has two open sides.
 29. The holder of claim 28,wherein the handle shelf wraps around one of the two open sides.
 30. Theholder of claim 23, wherein said holder further comprises means forholding an element selected from the group consisting of: a spinalneedle, a spinal needle sleeve, a spinal needle stylette, a spinalneedle sleeve holding a spinal needle, and a spinal needle sleeveholding a spinal needle and a stylette.
 31. The holder of claim 30,wherein said holder further comprises means for holding two or moreelements selected from the group consisting of: a spinal needle, aspinal needle sleeve, a spinal needle stylette, a spinal needle sleeveholding a spinal needle, and a spinal needle sleeve holding a spinalneedle and a stylette.
 32. The holder of claim 23, wherein said handleshelf has a plurality of openings for permitting the CSF collectioncontainers to pass therethrough.
 33. The holder of claim 23, whereinsaid bottom shelf contains indentations for receiving bottoms of the CSFcollection containers.
 34. The holder of claim 30, wherein said meansfor holding an element comprises openings in the top shelf member andthe inside shelf member.
 35. A holder for apparatus for the collectionof cerebrospinal fluid (CSF), for stably holding in a substantiallyupright position CSF collection containers, said holder comprising: ahorizontally disposed top shelf member having a plurality of firstopenings; a horizontally disposed inside shelf member having a pluralityof second openings, wherein the second openings are substantiallyaligned with the first openings in the top shelf member; a substantiallyhorizontally disposed handle shelf member; a horizontally disposedbottom shelf member against which the bottoms of the containers rest;substantially vertically disposed side panels connected to the top shelfmember, the inside shelf member, the handle shelf member, and the bottomshelf member; and means for holding an element selected from the groupconsisting of: a spinal needle, a spinal needle sleeve, a spinal needlestylette, a spinal needle sleeve holding a spinal needle, and a spinalneedle sleeve holding a spinal needle and a stylette.